Septal closure device with centering mechanism

ABSTRACT

In one aspect, the present invention provides a device for occluding an aperture in a body, for example, a patent foramen ovale (PFO), including a first side adapted to be disposed on one side of the septum and a second side adapted to be disposed on the opposite side of the septum. The device has an elongated, low-profile delivery configuration and a shortened, radially expanded deployment configuration. The first and second sides are adapted to occlude the aperture upon deployment of the device at its intended delivery location. The device also includes a radially expandable center portion. In some embodiments, the center portion includes a plurality of ribs provided by slits in device. The ribs expand radially when the device is deployed. The expandable center portion facilitates the positioning of the device in the aperture. The device can be secured in the deployed configuration using a catch system.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation of application Ser. No. 12/062,904,filed Apr. 4, 2008, which claims the benefit under 35 U.S.C. § 119(e) toU.S. Provisional Patent Application No. 60/921,969, entitled SeptalClosure Device With Centering Mechanism, filed Apr. 5, 2007, thecontents of which are incorporated by reference herein.

BACKGROUND OF THE INVENTION Field of the Invention

The invention relates generally to occlusion devices for closingphysical anomalies, such as an atrial septal defect, a patent foramenovale, and other septal and vascular defects.

Description of Related Art

A patent foramen ovale (PFO), illustrated in FIG. 1, is a persistent,one-way, usually flap-like opening in the wall between the right atrium11 and left atrium 13 of the heart 10. Because left atrial (LA) pressureis normally higher than right atrial (RA) pressure, the flap usuallystays closed. Under certain conditions, however, right atrial pressurecan exceed left atrial pressure, creating the possibility that bloodcould pass from the right atrium 11 to the left atrium 13 and bloodclots could enter the systemic circulation. It is desirable that thiscircumstance be eliminated.

The foramen ovale serves a desired purpose when a fetus is gestating inutero. Because blood is oxygenated through the umbilical chord, and notthrough the developing lungs, the circulatory system of the fetal heartallows the blood to flow through the foramen ovale as a physiologicconduit for right-to-left shunting. After birth, with the establishmentof pulmonary circulation, the increased left atrial blood flow andpressure results in functional closure of the foramen ovale. Thisfunctional closure is subsequently followed by anatomical closure of thetwo over-lapping layers of tissue: septum primum 14 and septum secundum16. However, a PFO has been shown to persist in a number of adults.

The presence of a PFO is generally considered to have no therapeuticconsequence in otherwise healthy adults. Paradoxical embolism via a PFOis considered in the diagnosis for patients who have suffered a strokeor transient ischemic attack (TIA) in the presence of a PFO and withoutanother identified cause of ischemic stroke. While there is currently nodefinitive proof of a cause-effect relationship, many studies haveconfirmed a strong association between the presence of a PFO and therisk for paradoxical embolism or stroke. In addition, there issignificant evidence that patients with a PFO who have had a cerebralvascular event are at increased risk for future, recurrentcerebrovascular events. The presence of a PFO has also been linked tochronic migraine headaches. Although researchers are still investigatingan explanation for the link, PFO closure has been shown to eliminate orsignificantly reduce migraine headaches in many patients

In certain cases, such as when anticoagulation is contraindicated,surgery may be necessary or desirable to close a PFO. The surgery wouldtypically include suturing a PFO closed by attaching septum secundum toseptum primum. This sutured attachment can be accomplished using eitheran interrupted or a continuous stitch and is a common way a surgeonshuts a PFO under direct visualization.

An atrial septal defect (ASD) is a defect in the septal wall of theheart between the heart's two upper chambers (the atria), and aventricular septal defect (VSD) is a defect in the septal wall betweenthe heart's two lower chambers (the ventricles). Septal defects of thistype are sometimes referred to as a “hole” in the heart. Meanwhile, apatent ductus arteriosus (PDA) is a persistent opening between the aortaand the pulmonary artery. While this connection is normal for a fetusgestating in utero, if the opening fails to close soon after birth, theopening can allow blood to flow directly from the aorta into thepulmonary artery, which can put strain on the heart and increased theblood pressure in the lung arties.

Umbrella devices and a variety of other similar mechanical closuredevices have been developed for percutaneous closure of the defectsdescribed above. However, because of the unique geometries of each typeof defect (e.g., PFO, ASD, VSD, or PDA), devices intended for one typeof defect may not be optimally suited for use in another type of defect.Moreover, adapting a device developed for one type of defect to anothertype of defect may present certain challenges. Even if a devicedeveloped for a particular type of defect can be deployed within adefect of another type, some components of the device may insecurelyseat against the septum and, thereby, risking thrombus formation due tohemodynamic disturbances.

In some cases, the size of the aperture is greater than the size of thecenter portion or other closure feature of the device. Upon deployment,such a device can slide toward one side within the aperture and thusocclude only one side or portion of the defect and result in a leak onthe other side. Finally, some septal closure devices are complex tomanufacture, which may result in inconsistent product performance.

The presently disclosed embodiments are designed to address these andother deficiencies of prior art septal closure devices.

BRIEF SUMMARY OF THE INVENTION

In one aspect, the present invention provides a device for occluding anaperture in the septum, including a first side adapted to be disposed onone side of the septum and a second side adapted to be disposed on theopposite side of the septum. The device has an elongated, low-profiledelivery configuration and a shortened, higher-profile deploymentconfiguration. The first and second sides are adapted to occlude theaperture upon deployment of the device at its intended deliverylocation. The device also includes a radially expandable center portion.The device can be secured in the deployed configuration using a catchsystem.

In one aspect, the device is formed from a tubular body. Slits oropenings are provided in the tubular body, either be cutting or byselectively bonding structural members such as filaments to define thebody. In some embodiments, axially extending slits evenly distributedaround the circumference of the distal portion of the tube define distalstruts and axially extending slits evenly distributed around thecircumference of the proximal portion of the tube define proximalstruts. The distal and proximal struts form loops in the deployedconfiguration. In some embodiments, the loops cover the sides of theaperture or provide a compressive force to the septal tissue surroundingthe aperture or both. A center portion connects the distal side and theproximal side of the occluder and extends through the aperture whendeployed. Axially extending slits evenly distributed around thecircumference of the center portion of the tube further define strutsthat expand radially to form ribs in the deployed configuration. Theribs provide an expandable center portion. The expandable center portionis separated from the distal loops by a distal joint and from theproximal loops by a proximal joint. The expandable center portionpositions and/or secures the device in the aperture, prevents the devicefrom shifting to one side, and prevents leaks. Accordingly, theexpandable center portion provides a self-centering mechanism.

The expandable center portion may include the same number or a differentnumber of struts than the distal and/or proximal portions of theoccluder. In some embodiments, the expandable center portion whenexpanded has a smaller diameter measured transverse to the axis of thetube than the distal or proximal loops. The ribs of the expandablecenter portion also are curved less sharply than the distal or proximalloops.

The tubular body may include a material selected from metals, shapememory materials, alloys, polymers, bioabsorbable polymers, andcombinations thereof. In particular embodiments, the tubular bodyincludes a shape memory polymer.

In another aspect, an occluder is formed by providing a first pluralityof axially-extending slits in a proximal portion, a second plurality ofaxially-extending slits in a center portion, and a third plurality ofaxially-extending slits in a distal portion.

In accordance with another aspect, an occluder is provided that isadapted to be introduced into a body through a vasculature. The occluderincludes a tube with a proximal side and a distal side that cooperate toclose the defect. The occluder also has a central portion disposedbetween the proximal side and the distal side. The central portion isoperable to expand when an axial length of the occluder is shortened.The tube includes slits to provide struts that are joined at the centralportion, wherein the struts form loops when the axial length of the tubeis shortened. In one aspect, the slits may comprise a first plurality ofaxially-extending slits in the proximal side, a second plurality ofaxially-extending slits in the central portion, and a third plurality ofaxially-extending slits in the distal side. A first uncut portion of thetube may provide a proximal joint, and a second uncut portion of thetube may provide a distal joint, such that the distal and proximaljoints are configured to maintain a tubular profile upon atransformation of the occluder to a deployed configuration.

In another with a further aspect, the loops are formed at the proximalside and the distal side of the occluder, and when the occluder issubjected to a compressive force, the loops form curves extending toconvergence areas that connect adjacent struts at distal and proximalends of the central portion, such that the central portion expandsuniformly in a radial direction, so that the occluder is self centeredwhen disposed in the defect. The locations of the convergence areas mayalternate in a circumferential direction of the central portion betweenthe distal end of the central portion and the proximal end of thecentral portion.

In another aspect, provided is a method for deploying an occludingmember having a series of loops formed by struts in a tube, the strutsbeing formed by a series of offset slits which are configured to formproximal side loops and distal side loops that are coupled to each otherby a central portion of the tube, such that when an axial length of thetube is shortened, the proximal side loops and the distal side loopsextend radially outwardly. A delivery system is inserted into a lumen ofa body for delivering the occluder; and a distal part of the occluder isdeployed so that the distal side loops expand to be disposed along asurface around a defect to be occluded. A catch element is moved throughan axially central passage of the occluder until the catch elementengages an area between the distal side loops and the central portion tohold the distal part of the device in a deployed state. The centralportion of the occluder is deployed so that the central portion isexpanded within an aperture of the defect. The axial length of theoccluder is shortened by moving the catch element through the axiallycentral passage of the occluder until the catch element engages an areabetween the central portion and the proximal side loops. A proximal partof the occluder is then deployed so that the proximate side loops aredisposed along a second surface around the defect to be occluded, andthe catch element is moved through the axially central passage of theoccluder until the catch element engages a proximal end of the occluder.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

FIG. 1 is a schematic representation of a human heart including variousseptal defects;

FIG. 2 is view of an occluder deployed in the heart of a patientaccording to an embodiment of the invention;

FIG. 3 is a schematic representation of the introduction of a cathetercontaining an occluder to the body of a patient;

FIG. 4 is a schematic representation of the introduction of a cathetercontaining an occluder according to an embodiment of the invention to adeployment site within the heart;

FIGS. 5-8 are isometric views of an embodiment of an occluder accordingto an exemplary embodiment of the present invention;

FIGS. 9-12 are schematic views of a deployment sequence for an occluderaccording to an embodiment of the invention;

FIG. 13 is view of an occluder deployed in the heart of a patientaccording to an embodiment of the invention;

FIGS. 14-17 are isometric views of an embodiment of an occluderaccording to an exemplary embodiment of the present invention;

FIG. 18 is a schematic representation of an occluder according to anembodiment of the invention in a compressed state;

FIG. 19 is a perspective view of an embodiment of an occluder with atissue scaffold; and

FIG. 20 is a perspective view of an embodiment of an occluder with atissue scaffold according to the present invention.

DETAILED DESCRIPTION

Embodiments consistent with the present invention provide a device foroccluding an aperture within body tissue. This device relatesparticularly to, but is not limited to, a septal occluder made from apolymer tube. In particular and as described in detail below, theoccluder of the present invention may be used for closing an ASD,ventricular septal defect (VSD) or PFO in the atrial septum of a heart.Although the embodiments of the invention are described with referenceto an ASD, VSD or PFO, one skilled in the art will recognize that thedevice and methods of the present invention may be used to treat otheranatomical conditions. As such, the invention should not be consideredlimited in applicability to any particular anatomical condition.

FIG. 1 illustrates a human heart 10, having a right atrium 11 and a leftatrium 13 and including various anatomical anomalies 18 a and 18 b. Theatrial septum 12 includes septum primum 14 and septum secundum 16. Theanatomy of the septum 12 varies widely within the population. In somepeople, septum primum 14 extends to and overlaps with septum secundum16. The septum primum 14 may be quite thin. When anatomical anomaliesare present, blood could travel through the passage 18 a (referred to as“the PFO tunnel”) or 18 b (referred to as an ASD) between septum primum14 and septum secundum 16.

The term “bioabsorbable,” as used in this application, is alsounderstood to mean “bioresorbable.”

In this application, “distal” refers to the direction away from acatheter insertion location and “proximal” refers to the directionnearer the insertion location.

FIG. 2 illustrates an embodiment of an occluder 20 according to oneaspect of the invention, deployed in a heart. The occluder 20, has adistal side 30 and a proximal side 40, disposed on respective sides ofthe aperture 18. The distal side 30 and the proximal side 40 includefeatures that cooperate to close the aperture 18, and, in certainembodiments, provide compressive force to hold the aperture 18 closed.Referring to occluder 20, distal side 30 and proximal side 40 areconnected by central portion 25. The occluder 20 may be inserted intothe septal tissue 12 to prevent the flow of blood through the aperture18, e.g., such that the distal side 30 is located in the left atrium 13and the proximal side 40 is located in the right atrium 11. The centralportion 25 is substantially disposed within aperture 18. Additionally oralternatively, the occluder 20 may be inserted into the septal tissue soas to prevent the flow of blood through the aperture 18, e.g., theoccluder may extend through the septum primum and septum secundum suchthat the distal side 30 is located in the left atrium 13 and theproximal side 40 is located in the right atrium 11. As used in thisapplication, unless otherwise indicated, the term “aperture 18” refersto any anatomical anomaly that may be treated by use of occluder 20,such as PFO 18 a, ASD 18 b, VSD (not shown), and/or PDA (not shown).FIG. 3 illustrates use of a catheter system 124, which can be externallymanipulated by a clinician, by insertion of a portion of catheter system124 into a patient's body 122 at a catheter insertion point 126 todeliver occluder 20. The distal end of the delivery assembly 124 isadvanced toward and into the heart 10 until the distal end is inproximity to the defect to be closed. FIG. 4 illustrates a detail viewof the introduction of catheter system 124 into the heart.

Referring now also to FIGS. 5-8, providing perspective views of theoccluder 20, in the illustrated embodiment, the occluder 20 isconstructed of one or more metal or polymer tube(s) or filaments,forming a body referred to collectively as tube 22. Tube 22 includesslits 31 and 41 and 51, which in some embodiments are formed using anetching or cutting process that produces a particular cutting pattern onthe tube 22. Other embodiments include slits formed by providingopenings wherein adjacent filaments are not bonded. Slits 31 are ofequal length, are radially even spaced and are disposed parallel to theaxis of the tube 22. For example, the slits 31 are cut along the axiallength of the upper half of the tube 22 using a cutting tool, e.g., arazor blade. According to some exemplary embodiments of the presentinvention the slits 31 are cut without removing any significant amountof material from tube 22, i.e., the formation of the slits 31 does notsignificantly reduce the overall volume of the tube 22. According toother embodiments of the present invention, the slits 31 are formed bycutting material out of the tube 22 such that the volume of the tube 22is reduced. Both ends of each of slits 31 may be rounded so as torelieve stresses at the axial ends of the slits 31. This helps preventthe slits 31 from lengthening due to cyclic stresses present in abeating heart and the resultant material fatigue. In those embodimentswhere the slits 31 are formed by cutting material out of the tube 22,the slits 41 and 51 are similarly formed.

An uncut portion of tube 22 between slits 41 and 51 provides a proximaljoint 53, and an uncut portion of tube 22 between slits 31 and 51provides a distal joint 55. In addition, the proximal end 60 and thedistal end 62 of the tube are also not cut. In the cut segments, slits31, 41 and 51 define a plurality of struts, respectively 32, 42 and 52.The occluder 20 is transformable from a delivery configuration to adeployed configuration. FIG. 5 closely approximates the deliveryconfiguration of the occluder 20. The transformation is represented inFIGS. 5-8, and the fully deployed condition, in a human heart, isillustrated in FIG. 2. The occluder 20 can be delivered via a catheterassembly such as catheter system 124 and has a tubular deliveryconfiguration well-suited to delivery via a catheter assembly. Thedeployed configuration is attained by shortening the axial length of thetube 22 and securing the occluder 20 in that configuration. Distal andproximal struts 32 and 42 form loops 35 and 45 respectively in theoccluder 20 in the deployed configuration. The center struts 52 formcurved ribs 57 that provide an expanding center portion 56 in thedeployed configuration. The deployed configuration and deploymenttechniques are discussed further below.

The shape of the occluder 20 in the deployed configuration is determinedby the cutting pattern on tube 22. For example, and as shown in FIG. 8,petal-shaped loops 35 and 45 are produced by cutting slits 31 in thedistal side 30 of tube 22, and cutting slits 41 in the proximal side 40of tube 22 according to the cutting pattern shown in FIG. 5. As shown inFIG. 5, the distal side 30 of tube 22 includes eight cuts 31, extendinglongitudinally and equally spaced apart around the circumference of thetube 22. Upon application of force F_(d) to end 62 to shorten the axiallength of distal portion 30, struts 32 bow and twist outward to formpetal-shaped loops 35 in distal side 30. The movement of the struts 31during deployment is such that the struts rotate in an orthogonal planerelative to the axis of the device. Center portion 25 may be constrainedduring the application of force F_(d), or any combination of forcessufficient to reduce the axial length of the distal portion of the tube22 may be applied to achieve this effect. One end of each ofpetal-shaped loops 35 originates from center portion 25, while the otherend originates from distal end 62. Petal-shaped loops 45 may be formedin proximal side 40 of tube 22 using the same cutting pattern describedabove.

The slits 51 provided in the center portion 25 also define struts 52.Struts 52 similarly bend outward when the tube 22 is compressed in theaxial direction. Unlike struts 32 and 42, struts 52 are not designed tobow and twist outward forming petal-like loops; instead, struts 52 curveoutward, forming curved ribs 57, shortening the axial length of centerportion 25 and widening the radius of center portion 25. The slits 51are shorter than the slits 41 and 31, forming shorter struts. Ribs 57have a gentler curve and incorporate low strain bends relative to thedistal and proximal loops 35 and 45. In some embodiments, the expandedradius of the center portion 25 is less than the expanded radius ofloops 35 and 45. In the illustrated embodiments, eight slits 51 areprovided in the center portion 25 of the occluder 20. Although here thenumber of slits 51 is the same as the number of slits 31 in the distalside and the number of slits 41 in the proximal side, different numbersof slits 51 can be provided in center portion 25 and the number of slitscan be different from the proximal side 40 and distal side 30.

Given that the surface of occluder 20 will contact septal tissue 12 onceit is deployed in vivo, slits 31 and 41 and 51 are cut so as to preventthe formation of sharp, potentially damaging edges along their length.For example, a heated cutting tool may be used to cut slits 31 and 41and 51 such that the material of tube 22 melts slightly when placed incontact with the cutting tool. Such melting rounds the edges of thesections. Lasers may also be used to cut slits 31 and 41 and 51.According to this process, the edges of loops 32 and 42 formed by thecutting of slits 31 and 41 and 51 are blunted (due to melting) toprevent tissue damage in vivo.

The distal side 30 of the occluder 20 (also called the “anchor portion”)includes eight loops (collectively referred to as loops 35). Aspreviously described, each of loops 35 are formed by corresponding cutsections forming struts 32, produced by cutting slits 31. Theapplication of force F_(d) to distal end 62 of tube 22 brings the axialends of slits 31 together such that struts 32 bow and twist outwardly toform loops 35 of distal side 30. Central portion 25, or moreparticularly, distal joint 55, may be constrained during the applicationof force F_(d). One skilled in the art will recognize that anycombination of forces sufficient to reduce the axial length of the tube22 would be sufficient to deploy the distal side 30 of occluder 20.

As illustrated, the loops 35 are evenly distributed about the tube 22and end 62. Thus, when the distal side 30 includes eight loops 35, theeight slits 31 are spaced 45 degrees radially apart. Similarly, when thedistal side 30 includes six loops 32, the six slits 31 are spaced 60degrees radially apart. The angle between radially equally-spaced loopsis determined by the formula (360/n_(d)), where n_(d) is the totalnumber of loops 32.

Although the distal side 30 of the occluder 20 eight loops 35, occludersaccording to an exemplary embodiment of the present invention mayinclude any number of loops 35 necessary for a given application. Inparticular embodiments, the distal side 30 of occluder 20 includes sixloops 35. Occluders having between four and ten loops 35 may be formedwithout requiring significant adjustments in the processes described inthis application. However, occluders having less than four or more thanten loops 35 may be complicated to manufacture and difficult deliverthrough the vasculature.

Regardless of the number of loops 35 included in distal side 30 anddepending upon the material used to form occluder 20, the outerperimeter of loops 35 may vary. In some embodiments, the loops on oneside are of equal diameter. In at least some embodiments, the outerperimeter of loops 35 is rounded to provide an occluder 20 having asmooth, circular perimeter. As the number of loops 35 in the distal side30 of occluder 20 increases, it becomes desirable to round the outerperimeters of the loops 35 so as to prevent the infliction of trauma onthe surrounding septal tissue 12. The outer perimeter of the loops 35may bend inwardly more than inner portions of the loops 35 to provide aforce distribution that helps secure the occluder 20 in place.

The proximal side 40 of the occluder 20 also includes eight loops(collectively referred to as loops 45). As previously described, each ofloops 45 are formed by corresponding cut sections forming struts 42,produced by cutting slits 41. The application of force F_(p) to proximalend 60 of tube 22 brings the axial ends of slits 41 together such thatstruts bow and twist outwardly to form loops 45 of proximal side 40.Central portion 25, or more particularly proximal joint 53, may beconstrained during the application of force F_(p). One skilled in theart will recognize that any combination of forces sufficient to reducethe axial length of the tube 22 would be sufficient to deploy theproximal side 40 of occluder 20. As described above for distal loops 35,the loops 45 are evenly distributed about central portion 25. Similarly,the angle between radially equally-spaced slits 41 in the proximal side40 is determined by the formula (360/n_(d)), where n_(d) is the totalnumber of loops 45.

Although the proximal side 40 of the occluder 20 has eight loops 45, oneskilled in the art will recognize that the proximal side 40 of anoccluder according to the present invention may include any number ofloops 45 required and suitable for a given application. In particularembodiments, the proximal side 40 of occluder 20 includes six loops 45.Further, although as illustrated, distal side 30 and proximal side 40both include eight loops, there is no requirement that distal side 30and proximal side 40 of occluder 20 include the same number of loops. Infact, in particular applications, it may be advantageous to use anoccluder 20 in which the distal side 30 contains fewer loops than theproximal side 40, or vice versa.

It will be apparent to one skilled in the art that loops 35 and loops 45do not have to be the same size, although they could be. In oneembodiment, loops 35 are larger in size than loops 45. In anotherembodiment, loops 35 are smaller in size than loops 45. Size of loops 35and 45 is determined by the lengths of slits 31 and 41 respectively.Therefore, absolute and relative lengths of slits 31 and 41 can bevaried to achieve desired absolute and relative sizes of loops 35 and45.

In at least some embodiments, loops 45 of the proximal side 40 areradially offset from loops 35 of the distal side 30 to provide a betterdistribution of forces around the aperture 18. This can be achieved bymaking cuts to create slits 31 and 41 such that they are radially offsetrelative to each other. The maximum degree of offset will depend on thenumber of slits. In general, if slits are equally spaced, the maximumpossible offset will be one half of the angle between the loops. Forexample, if distal side 30 (or proximal side 40) contains 4 slits (andtherefore 4 loops), loops will be 90 degrees apart (see the formuladescribed above), thereby allowing for maximum degree of offset of onehalf of 90 degrees (which is 45 degrees) between loops 35 and loops 45.In a preferred form, when distal side 30 (or proximal side 40) contains4 slits (and therefore 4 loops), loops 45 and loops 35 are offset by 45degrees. In an alternative embodiment, the degree of offset betweenloops 35 and 45 ranges from about 30 to about 45 degrees. In otherembodiments, rather than forming loops 35 and 45, either one or both ofthe distal or proximal struts 32 and 42 can be formed to bend at theoutermost point, forming a V shape. In various embodiments, many othervariations on loops 35 and 45 are possible. For example, loops 35 and 45can be formed by angled cuts, individual loops can be formed by slits ofdifferent shapes, including slits that are not straight, individualloops can have varying dimensions, and slits can be formed to providethick and thin segments or to predispose bending at certain points. Inother embodiments, the loops 35 and 45 could be radially offset.Considerations that may be important for the design of loops 35 and 45include providing sufficient compressive force to the septal tissue toclose the aperture, sufficient stiffness to withstand deploymentstresses, improved collapsibility and/or transformability, improvedconformance with anatomical landmarks, or the anatomy of an individualpatient's heart. In some embodiments, the loops 35 and 45 could beformed according to a different cutting pattern, wherein to form eitherof loops 35 or 45, one portion of the tube is cut in half to form halfsections and the half sections are further cut from a middle portion toa proximal distance from the end to split them into quarter sectionsalong a length. The cuts are discontinued and one pair of quartersections form one half section at the end, and one pair of quartersections form another half section at the end. Adjacent loops share acommon strut along a portion (i.e., provided by the half sections.) Thisembodiment of the loops is further described and illustrated in U.S.application Ser. No. 10/890,784, incorporated by reference herein,particularly FIGS. 2A through 2D.

The center slits 51 define struts 52 that arc outward in the deployedconfiguration. The struts 52 form curved ribs 57 that provide anexpandable center portion 56. In some embodiments, the distal joint 55and the proximal joint 53 are disposed on either side of the expandablecenter portion 56. Given that the distal and proximal joints 55 and 53are not cut and do not include openings, they maintain the tubularprofile upon the transformation of the occluder 20 to the deployedconfiguration. The expandable center portion 56 is thus distinct andseparated from the distal and proximal loops 35 and 45. The expandablecenter portion 56 is adapted to be seated within the aperture 18, beingclosed by the occluder 20. The expandable center portion 56 provides aflexible, secure fit within the aperture 18 and prevents the occluder 20from sliding to one side or the other once it has been deployed. Theexpanded center portion 56 controls the position of the occluder 20within or over a defect. The expandable center portion 56 canaccommodate the anatomical variability of cardiac defects, withoutrequiring an occlusion device that has an overall larger size. Occluder20, therefore, can be used in patients with varying size cardiacdefects, without interfering with other anatomical features of the heartand without incurring unduly high stress levels once deployed. In thedeployed configuration, the center portion 56 may be subject to radiallyinward compressive force or may be fully expanded, depending on the sizeof the aperture 18 in the individual patient. In some embodiments, thestruts 52 could also form other configurations than curved ribs 57 inthe deployed configuration, such as curved loops or flat loops or flator bent ribs, thereby providing center portions with different profiles,and diameters in particular, and different radial forces.

Although the center portion 25 is illustrated as being axially alignedwith the distal portion 30 and the proximal portion 40, in someembodiments, the center portion 25 could be angled relative to one sideor both sides. An occluder having a straight center portion 25 isparticularly suited to treat an anatomical anomaly including aperpendicular aperture, such as an ASD or certain PFOB. Often however,anatomical anomalies such as certain PFOB, have non-perpendicularapertures and are sometimes quite significantly non-perpendicular. Anangled center portion 25 is well-suited to treat such defects becausethe angle is more likely to match the orientation of the defect. Theangle can be from about 0 to about 45 degrees in some embodiments. Also,the length of the central portion 25 and the relative length of slits 51can be varied depending on the anatomy of the defect being closed.

The tube(s) 22 forming occluder 20 includes a biocompatible metal orpolymer. In at least some embodiments, the occluder 20 is formed of abioabsorbable polymer, or a shape memory polymer. In other embodiments,the occluder 20 is formed of a biocompatible metal, such as a shapememory alloy (e.g., nitinol). The thermal shape memory and/orsuperelastic properties of shape memory polymers and alloys permit theoccluder 20 to resume and maintain its intended shape in vivo despitebeing distorted during the delivery process. In addition, shape memorypolymers and metals can be advantageous so that the structure of thedevice assists in compressing the PFO tunnel closed. Alternatively, oradditionally, the occluder 20 may be formed of a bioabsorbable metal,such as iron, magnesium, or combinations of these and similar materials.Exemplary bioabsorbable polymers include polyhydroxyalkanoatecompositions, for example poly-4-hydroxybutyrate (P4HB) compositions,disclosed in U.S. Pat. No. 6,610,764, entitled PolyhydroxyalkanoateCompositions Having Controlled Degradation Rate and U.S. Pat. No.6,548,569, entitled Medical Devices and Applications ofPolyhydroxyalkanoate Polymers, both of which are incorporated herein byreference in their entirety.

The cross-sectional shape of tube 22 may be circular or polygonal, forexample square, or hexagonal. The slits 31 and 41 and 51 may be disposedon the face of the polygon (i.e., the flat part) or on the intersectionof the faces.

The tube 22 can be extruded or constructed of a sheet of material androlled into a tube. The sheet of material could be a single ply sheet ormultiple ply. The slits that form the struts could be cut or stampedinto the tube prior to rolling the tube to connect the ends to form anenclosed cross section. Various geometrical cross sections are possibleincluding circular, square, hexagonal and octagonal and the joint couldbe at the vertex or along the flat of a wall if the cross section is ofa particular geometry. Various attachment techniques could be used tojoin the ends of the sheet to form a tube, including welding, heatadhesives, non-heat adhesives and other joining techniques suitable forin-vivo application.

In alternate embodiments, the occluder 20 can be formed by aligning andselectively bonding a plurality of filaments to provide a similargeometry. In such filament-based embodiments, occluder 20 is preferablyformed without cutting. References to a tube 22 as used herein aregenerally intended to include a tube-formed body or a filament-formedtubular body. One of skill in the art will appreciate that in lieu of“cutting” slits, slits are formed in some embodiments by selectivebonding to leave openings. One of skill in the art will appreciate thatoccluder 20 if formed by bonding filaments, rather than by cutting atube, will have different structural properties and will behavedifferently under physical stresses than an occluder formed by cutting.Techniques for forming occluders by bonding rather than by cutting aredescribed in U.S. application Ser. No. 11/728,694, entitled PatentForamen Ovale (PFO) Closure Device with Linearly Elongating Petals,filed Mar. 27, 2007, incorporated herein by reference.

The surface of tube 22 may be textured or smooth. An occluder 20 havinga rough surface produces an inflammatory response upon contact withseptal tissue 12 in vivo, thereby promoting faster tissue ingrowth,healing, and closure of aperture 18 a (shown in FIG. 1). Such a roughsurface may be produced, for example, by shaving tube 22 to producewhiskers along its surface. For example, the tube 22 may include suchwhiskers. Additionally or alternatively, the surface of tube 22 may beporous to facilitate cell ingrowth.

The tube 22 can also be preformed or partially preformed to have itsdeployed configuration, in order to shape the curves and bends of therespective loops and ribs. In some embodiments, the loops 35 and 45 arepreformed, but the ribs 57 are not preformed. This can be desirablebecause the loops 35 and 45 bend more sharply than the ribs 57, and thesharp bending can be facilitated by preforming.

According to some embodiments of the invention, occluder 20 is fixed inthe deployed configuration with a cooperating catch system, preferablycomprising a catch member. In certain embodiments, a catch memberdesigned for use with the occluder 20 has tubular catch body, a distalflange for engaging the distal end 62 of the tube and a proximal catchmechanism for engaging the proximal end 60 of the tube. The catch memberis disposed in a central axial passage in the tube 22 and is shorterthan the elongated axial length of the tube 22. For deployment, one endof the tube 22, typically the proximal end is able to slide distally,when the appropriate forces are applied, over the catch member,shortening the axial length of the tube 22. When the proximal catchmechanism is engaged, the occluder tube 20 is fixed in the deployedconfiguration. The proximal catch mechanism could be a deformable flap,a threaded catch mechanism, a collapsible ridge or other mechanism forholding the proximal end 60 of the occluder 20 fixed relative to thedistal end 62 and preventing it from moving proximally. Some embodimentsof catch members that are suitable for use with the presently disclosedembodiments are discussed in applications referenced below, which areincorporated herein by reference. One skilled in the art will recognizethat the catch system may assume numerous configurations while retainingits capability to reduce and maintain the axial length of occluder 20 sothat occluder 20 maintains it deployed state. One exemplary embodimentof a catch member and its deployment is schematically illustrated inFIGS. 9-12, discussed further below.

FIGS. 9-12 illustrate a deployment sequence for occluder 20 according toan embodiment of the invention. A delivery assembly 200 for deliveringand deploying the occluder 20 to the desired site, i.e., aperture 18, isshown. Delivery assembly includes a delivery sheath 210, the lumen ofwhich contains at its distal end occluder 20 in its low-profile,elongated delivery configuration and catch member 100 disposed withinthe axial passage of the occluder 20. The delivery sheath 210 furthercontains a delivery catheter 220 slidably disposed within the deliverysheath 210 and a delivery wire 230 slidably disposed within a lumen ofdelivery catheter 220. The delivery catheter 220 connects to theproximal end 60 of the occluder 20. In the illustrated embodiment, theconnection is a threaded connection to threaded portion 70 of proximalend 60. The delivery wire 230 connects to a proximal end of the catchmember 100. The components of delivery assembly 200 are dependent on,among other factors, the catch mechanism that is used. The deliveryassembly should enable application of the appropriate forces to shortenthe axial length of the occluder and engage the catch system. In theillustrated embodiment, the catch member 100 provides a deformable flapcatch mechanism. The catch member 100 has a distal flange 110, anelongated catch body 120, and a proximal deformable flap 130. Thedelivery wire can connect to the proximal end of the catch member 100 bya threaded catch mechanism, for example. Delivery assemblies suitablefor use with the occluder 20 are discussed in applications referencedbelow, which are incorporated herein by reference, and particularly U.S.application Ser. No. 11/235,661, entitled Occluder Device DoubleSecurement System For Delivery/Recovery Of Such Occluder Device, filedSep. 25, 2005. However, it is understood that other delivery systems maybe used with the embodiments disclosed here, and, thus, the invention isnot limited to any particular delivery system.

As delivery assembly 200, as shown in FIG. 9, is used to deliver thecomponents to the desired implantation site. In its elongated,low-profile configuration, the occluder 20 is readily deliverablethrough a catheter system as shown. The delivery assembly 200 isintroduced to a distal side of the aperture 18 (not shown). FIG. 10illustrates a step in the deployment process. The delivery sheath 210 isretracted (or the internal components advanced) to expose the distalside 30 of the occluder 20 and the catch member 100. The proximal end ofthe catch member 100 is advanced in the proximal direction relative tothe distal portion 30 of the occluder 20, until the flap 130 engages thedistal joint 55. This step shortens the axial length of the distalportion 40, causing the bending of struts 32 and the expansion of theprofile of the distal portion 30 of the occluder 20.

As shown in FIG. 11, the expanding center portion 56 is then deployed inthe aperture (not shown) using a similar series of steps. The deliverysheath 210 is withdrawn to expose the center portion 25. The proximalend of the catch member 100 is advanced in the proximal directionrelative to the center portion 25 until the flap engages the proximaljoint 53. This step shortens the axial length of the center portion 25(and further shortens the axial length of distal portion 30), causingthe bending of struts 52 and the expansion of the profile of the centerportion 25. The distal loops 35 continue to form.

As shown in FIG. 12, the proximal portion 40 is then deployed on theproximal side of the aperture (not shown) using a similar series ofsteps. The delivery sheath 210 is further retracted to expose theproximal portion 40. The proximal end of the catch member 100 isadvanced in the proximal direction relative to the center portion 25until the flap 130 engages the proximal end 60. This step shortens theaxial length of the occluder 20, causing the bending of struts 42 andthe expansion of the profile of the proximal portion 40. This stepcompletes the transformation to the deployed configuration of occluder20. Loops 35 and 45 and ribs 57 are fully formed upon completion of thisstep. The deployment is completed by releasing and withdrawing thedelivery assembly 200. The fully deployed occluder 20 is illustrated inFIG. 2. When fully deployed, occluder 20 rests within the aperture 18,and the distal side 30 and proximal side 40 exert a compressive forceagainst septum primum and septum secundum in the left and right atria,respectively to close the aperture 18. If the deployment is notsatisfactory, the occluder 20 can be retrieved and redeployed. Thetechniques disclosed for deploying the embodiments described herein areonly one example of a deployment technique, it being understood thatother techniques can be used instead of, or in combination with, thosedisclosure. For example, the techniques used to deploy an embodiment ofthe occluders described herein will depend on the particular features ofthe occluder, the delivery system, and the anatomy in which the occluderis being deployed.

FIG. 13 illustrates an embodiment of the occluder 300 according to afurther aspect of the invention. Similar to the embodiment of FIG. 2,the occluder 300 has a distal side 304 and a distal end 306, along witha proximal side 308 and a proximal end 310, disposed on respective sidesof an aperture 18. The distal side 304 and the proximal side 308 includefeatures that cooperate to provide a compressive force against theseptum primum and the septum secundum when in the deployed position. Thedistal side 304 and proximal side 308 are connected by a central portion312, which is discussed below in more detail. The occluder 300 may beinserted into the septal tissue, e.g., septum secundum and/or septumprimum, such that the distal side 304 is located in the left atrium 13,the proximal side 308 is located in the right atrium 11, and theexpandable central portion 312 provides a self centering mechanism.

In FIG. 13, the aperture 18 in the septum primum 14 may be an ASD. Thus,occluder 300 may be deployed within aperture 18 to occlude this type ofdefect. Although not shown in the figure, an ASD may also exist in theseptum secundum 16. Occluder 300 may also be deployed in an ASD in thisportion of the septal tissue. Aperture 18 in the septum primum 14 canalso be a man-made aperture created for the purpose of occluding aPFO-type of defect. In such a case, the proximal loops 360 of theoccluder 300 are sized so as to overlap a portion of the septum secundum16 and pinch the PFO closed. The distal loops 356 are sized tocompliment the size of the proximal loops 360. In this configuration,the occluder 300 applies a compression force to the septum primum 14 andseptum secundum 16 without being disposed in the PFO tunnel 18. However,it is understood that the occluder 300 can also be deployed within thePFO tunnel 18, as described herein.

Referring now also to FIGS. 14-18, providing perspective views of theoccluder 300, in the illustrated embodiment, the occluder 300 maybeconstructed of one or more metal or polymer tube(s) or filaments,forming a body referred to collectively as tube 316. Tube 316 includesslits 364, 368, 372, and 376, etc., which in some embodiments may beformed using an etching or cutting process that produces a particularcutting pattern on tube 316. Similar to previous embodiments, it will beappreciated that the slits may extend around the entire circumference ofthe tube in accordance with the patterning represented in FIG. 14.

The formation of the slits 364, 368, 372, and 376 provide struts aroundthe tubes' 316 circumference. For example, as shown in FIG. 14, struts336, 340, 344 and 348 extend from the proximal side 308 of the tube 316,and the struts 336′, 340′, 344′ and 348′ extend from the distal side 304of the tube 316, so as to be joined with adjacent struts at convergenceareas or joints 350 and 352 (shown in FIG. 15). For example, theconvergence area 350 is provided where the struts 336 and 340 arejoined, and convergence area 352 is provided where struts 340′ and 344′are joined. The joints 350 and 352 maybe repeated around thecircumference to the tube 316 to form a zigzag pattern at the expandedcentral portion 312 as illustrated in the exemplary embodiment of FIG.18. Due to the nature of the slits, the corresponding struts, e.g., 336and 336′, may in some embodiments be considered to form one continuousstrut, as show in the figures.

The occluder 300 is transformable from a delivery configuration to adeployed configuration. FIG. 14 approximates the delivery configurationof the occluder 300. The transformation is represented in FIGS. 14-17,and the fully deployed condition, in a human heart, is illustrated inFIG. 13. Similar to the previous embodiment, the occluder 300 can bedelivered via a catheter assembly, such as catheter system 124, shown inFIG. 3, and has a tubular delivery configuration well-suited fordelivery via the catheter system 124. The deployed configuration isattained by shortening the axial length of the tube 316 and catching theoccluder 300 in that configuration. Portions of the struts 336, 340, 344and 348 at the proximal side 308 form loops 360, and portions of thestruts 336′, 340′, 344′ and 348′ at the distal side 304 form loops 356when the occluder 300 is in the deployed configuration. As a compressionforce is applied and the loops 356 and 360 extend in the radialdirection, an outward force is exerted onto the center portion 312 toassist the center portion 312 in radially expanding, as shown by thesize progression of the central portion 312 in FIGS. 14-17. Accordingly,the central portion 312 is subject to a uniform distribution of forcescausing the respective portions of the struts and joints in the centralportion 312 to be displaced outwardly by a uniform amount, providing thecentral portion with a cylindrical-like appearance with ends thateventually curve outwardly near the convergence areas 350 and 352.

The shape of the occluder 300 in the deployed configuration isdetermined by the cutting pattern on tube 316. For example, and as shownin FIGS. 13, 17 and 18, the petal-shaped loops 356 and 360 are producedby cutting slits 364 and 368 in the proximal side 308 of tube 316, andcutting slits 372 and 376 in the distal side 304 of tube 316 accordingto the cutting pattern shown in FIG. 14. The slits 364, 368, 372 and 376may be longitudinally and equally spaced apart around the circumferenceof the tube 316. The slits 364 and 368 alternative in length such thatthe slits 364 extend further in the axial direction toward the centerportion 312 than slits 368. Similarly, the slits 372 and 376 alternativein length such that the slits 376 extend further in an opposite axialdirection toward the center portion 312 than the slits 372. It will beappreciated that the pattern formed by the slits 364, 368, 372 and 376may be repeated around the circumference of the tube occluder 300. Slits364 may extend to overlap with at least a portion of slits 376. Thelengths and positioning of slits 364, 368, 372 and 376 contribute to thecentral portion 312 exhibiting substantially uniform expansion in thearea between the convergence points 350 and 352, to provide a morebalanced distribution of forces along the center portion 312 and helpprevent the center portion 312 from be biased to any one side of theseptum primum, as shown in FIG. 13. By altering the length of the slits,the convergence areas 350 and 352 are located at different points alongthe axial direction, and can be patterned to provide the expandedcentral portion 312 with the zigzag pattern, show in the exemplaryembodiment of FIG. 18.

Upon application of force F_(d) to end 306 to shorten the axial lengthof distal side 304, struts 336′, 340′, 344′ and 348′ bow and twistoutward to form the petal-shaped loops 356 in distal side 304. Themovement of the struts 336′, 340′, 344′ and 348′ during deployment issuch that the struts rotate in an orthogonal plane relative to the axisof the device. The petal-shaped loops 356 bend outwardly from centerportion 312 and terminate towards the end 306. The struts 336, 340, 344and 348 of the proximal side 308 act in a similar manner when a forceF_(p) is applied.

The expandable center portion 312 extends into the distal and proximalloops 356 and 360. The expandable center portion 312 is adapted to beseated within the aperture 18, being closed by the occluder 360. Theexpandable center portion 312 provides a flexible, secure fit and helpsprevent the occluder 360 from sliding to one side or the other once ithas been deployed.

Certain embodiments of the present invention have certain similaritiesto devices and/or may be used with a number of delivery and catchsystems such as those described in U.S. application Ser. No. 10/731,547,entitled Septal Closure Devices, filed Dec. 9, 2003; U.S. applicationSer. No. 11/121,833, entitled Catching Mechanisms for Tubular SeptalOccluder, filed May 4, 2005; U.S. application Ser. No. 11/235,661,entitled Occluder Device Double Securement System for Delivery/Recoveryof such Occluder Device, filed Sep. 26, 2005; U.S. application Ser. No.11/384,635, entitled Catch Member for PFO Occluder, filed Mar. 20, 2006;U.S. application Ser. No. 11/644,373, entitled Catch Members forOccluder Devices, filed Dec. 21, 2006; U.S. application Ser. No.11/111,685, entitled Closure Device with Hinges, filed Apr. 21, 2005;U.S. application Ser. No. 11/729,045, entitled Screw Catch Mechanism forOccluder and Method of Use, filed Mar. 28, 2007; U.S. application Ser.No. 11/729,637, entitled Deformable Flap Catch Mechanism for OccluderDevice, filed Mar. 29, 2007; U.S. application Ser. No. 11/728,694,entitled Patent Foramen Ovale (PFO) Closure Device with LinearlyElongating Petals, filed Mar. 27, 2007; U.S. application Ser. No.11/904,545, entitled Implant Catheter Attachment Mechanism Using Snareand Method of Use, filed Sep. 27, 2007, and U.S. application Ser. No.11/395,718, entitled Tubular Patent Foramen Ovale (PFO) Closure DeviceWith Catch System, filed Mar. 31, 2006, all of which have the sameassignee as the present application and are herein incorporated byreference.

In some embodiments, the device includes a tissue scaffold. In variousembodiments, the tissue scaffold can be formed of any flexible,biocompatible material capable of promoting host tissue growthincluding, but not limited to, polyester fabrics, Teflon-basedmaterials, such as ePTFE, polyurethanes, metallic materials, polyvinylalcohol (PVA), extracellular matrix (ECM) isolated from a mammaliantissue, or other bioengineered materials, bioabsorbable polymers, orother natural materials (e.g., collagen), or combinations of thesematerials. Furthermore, the surface of the tissue scaffold can bemodified with biological, pharmaceutical and/or other activeingredients, such as anti-coagulants, anti-thrombogenic agents, cells,growth factors and/or drugs to improve defect healing and/or to preventblood clotting. The scaffold can be attached to a cardiovascularoccluder frame or to another scaffold by sutures, heat treatment,adhesives, or any other chemical bonding process.

A tissue scaffold is described and illustrated with respect to theoccluders 20 and 360 in FIGS. 19 and 20; however, a tissue scaffold usedwith the present exemplary embodiments may be in the form of anysuitable embodiments described in U.S. application Ser. No. 11/904,137,entitled Scaffold For Tubular Septal Occluder Device And Techniques ForAttachment, filed Sep. 26, 2007, which application has the same assigneeas the present application and is incorporated herein in its entirety byreference.

As shown in FIG. 19, a scaffolded occluder 20 includes the occluder 20and a tissue scaffold 380. In this embodiment, the tissue scaffold 380completely encapsulates the occluder petals 35 and 45, and the centralportion 25. The coverage provided by tissue scaffold 380 offers severalaspects, including that the tissue scaffold 380 improves the sealing ofthe aperture being closed. Another advantage is that the tissue scaffoldcan enhance the implant's stability at the desired delivery location.The tissue scaffold can allow and facilitate the ingrowth of tissue, andcertain pharmacological agents can be applied or embedded in the tissuescaffold for delivery to the implant site. The tissue scaffold 380includes seams, such as seams 384 and 388. The presence of such seamsmay impact the dimensions of the occluder, the size of delivery catheterto be used and other aspects of the use of the occluder.

As shown in FIG. 20, a scaffolded occluder 300 includes the occluder 300and a tissue scaffold 390. Similar to the above embodiment, in theembodiment of FIG. 15B the tissue scaffold 390 completely encapsulatesthe occluder petals 356 and 360, and the central portion 312. The tissuescaffold likewise 390 includes seams, such as seams 394 and 398.

One skilled in the art will recognize that the occluders describedherein may be used with various drugs, growth factors, and/or otheragents to improve defect healing and/or to prevent blood clotting. Suchagents include but not limited to Adenovirus with or without geneticmaterial; Angiogenic agents; Angiotensin Converting Enzyme Inhibitors(ACE inhibitors); Angiotensin II antagonists; Anti-angiogenic agents;Antiarrhythmics; Anti-bacterial agents; Antibiotics: Erythromycin,Penicillin; Anti-coagulants: Heparin; Anti-growth factors;Anti-inflammatory agents: Dexamethasone, Aspirin, Hydrocortisone;Antioxidants; Anti-platelet agents; Forskolin; Anti-proliferationagents; Anti-rejection agents; Rapamycin; Anti-restenosis agents;Antisense; Anti-thrombogenic agents; Argatroban Hirudin; GP IIb/IIIainhibitors; Antivirus drugs; Arteriogenesis agents; acidic fibroblastgrowth factor (aFGF); angiogenin; angiotropin; basic fibroblast growthfactor (bFGF); Bone morphogenic proteins (BMP); epidermal growth factor(EGF); fibrin; granulocyte-macrophage colony stimulating factor(GM-CSF); hepatocyte growth factor (HGF); HIF-1; insulin growth factor-1(IGF-1); interleukin-8 (IL-8); MAC-I; nicotinamide platelet-derivedendothelial cell growth factor (PD-ECGF); platelet-derived growth factor(PDGF); transforming growth factors alpha & beta (TGF-a, TGF-b); tumornecrosis factor alpha (TNF-a); vascular endothelial growth factor(VEGF); vascular permeability factor (VPF); Bacteria Beta blocker; Bloodclotting factor; Calcium channel blockers; Carcinogens; Cells; Bonemarrow cells; Blood cells; Stem Cells; Umbilical cord cells; Fat cells;Chemotherapeutic agents (e.g. Ceramide, Taxol, Cisplatin); Cholesterolreducers; Chondroitin Collagen Inhibitors; Colony stimulating factors;Coumadin; Cytokines; prostaglandins; Dentin Etretinate Genetic material;Glucosamine; Glycosaminoglycans; L-703, 081; Growth factor antagonistsor inhibitors; Growth factors; Autologous Growth Factors; Basicfibroblast growth factor (bFGF); Bovine Derived Growth Factors;Cartilage Derived Growth Factors (CDF); Endothelial Cell Growth Factor(ECGF); Fibroblast Growth Factors (FGF); Nerve growth factor (NGF);Recombinant NGF (rhNGF); Recombinant Growth Factors; Tissue DerivedCytokines; Tissue necrosis factor (TNF); Growth hormones; Heparinsulfate proteoglycan; HMC-CoA reductase inhibitors (statins); Hormones;Erythropoietin; Immoxidal; Immunosuppressant agents; inflammatorymediator; Insulin; Interleukins; Lipid lowering agents; Lipo-proteins;Low-molecular weight heparin; Lymphocytes; Lysine; Morphogens Nitricoxide (NO); Nucleotides; Peptides; PR39; Proteins; Prostaglandins;Proteoglycans; Perlecan Radioactive materials; Iodine—125; Iodine—131;Iridium—192; Palladium 103; Radiopharmaceuticals; Secondary Messengers;Ceramide; Somatomedins; Statins; Steroids; Sulfonyl Thrombin; Thrombininhibitor; Thrombolytics; Ticlid; Tyrosine kinase; Inhibitors; ST638;AG17; Vasodilator; Histamine; Nitroglycerin; Vitamins E and C; Yeast.The occluders could also be modified so as to deliver one or morealarmin(s) or alarmin activator(s), or a combination of alarmin(s) andalarmin activator(s) to the intracardiac tissue to be treated toaccelerate recruitment of endogenous cells, for example, fibroblasts,myocytes, endothelial cells and their progenitors, and progenitor cellsof the circulating blood, formation of granulation tissue andre-endothelialization at the site of the intracardiac defect. Exemplaryalarmins include members of the family of damage associated molecularpattern molecules (DAMPs) and members of the family of pathogenassociated molecular pattern molecules (PAMPs). Exemplary alarminsfurther include the nuclear protein HMGB1, the S100 family of molecules(cytosolic calcium-binding proteins), heat shock proteins, interleukins(including IL-1a), HDGF (hepatoma-derived growth factor, Gall(Galectin 1) and the purinergic metabolites of ATP, AMP, adenosine anduric acid. Alarmin activators include small molecules necessary formaintaining the activity of administered and/or endogenous alarmins.Exemplary alarmin activators include thiol containing reducing agents,including, but not limited to, dithiothreitol, 2-mercaptoethanol,N-7-acetyl-cysteine, sodium sulfite, glutathione, and Probucol™(2,6-ditert-butyl-4-[2-(3,5-ditertbutyl-4-hydroxyphenyl)sulfanylpropan-2-ylsulfanyl]phenol).Exemplary alarmin activators further include non-thiol reducing agents,including, but not limited to, ascorbic acid, sodium hypophosphite, andsodium borohydride.”

One skilled in the art will further recognize that occluders accordingto the invention could be used to occlude other vascular andnon-vascular openings. For example, the device could be inserted into aleft atrial appendage or other tunnels or tubular openings within thebody.

Various embodiments have been illustrated and described herein by way ofexample, and one of skill in the art will appreciate that variation canbe made without departing from the spirit and scope of the invention.

What is claimed is:
 1. A device for occluding a defect in a body, thedevice comprising: an occluder body that defines a longitudinal axis,the occluder body being reconfigurable from an elongated deliveryconfiguration to a shortened and radially expanded deployedconfiguration, the occluder body comprising: a proximal end portion; aproximal convergence area that is positioned distal of the proximal endportion; a plurality of proximal-side struts that extend between theproximal end portion and the proximal convergence area to define aproximal side; a distal convergence area that is positioned distal ofthe proximal convergence area; a plurality of central struts that extendbetween the proximal convergence area and the distal convergence area todefine a central portion, wherein portions of the plurality of centralstruts are non-overlapping and form a substantially cylindrical areawhile the occluder body is configured in the deployed configuration; adistal end portion that is positioned distal of the distal convergencearea; and a plurality of distal-side struts that extend between thedistal convergence area and the distal end portion to define a distalside, wherein each of the proximal end portion, the proximal convergencearea, the distal convergence area, and the distal end portion aredisposed generally coaxially in relation to the longitudinal axis whilethe occluder body is configured in the delivery configuration, whereinwhile the occluder body is configured in the delivery configuration eachof: (i) the plurality of proximal-side struts, (ii) the plurality ofcentral struts, and (iii) the plurality of distal-side struts arearranged radially outward from the longitudinal axis while each of: (a)the proximal end portion, (b) the proximal convergence area, (c) thedistal convergence area, and (d) the distal end portion remain disposedgenerally coaxially in relation to the longitudinal axis and in thedeployed configuration, a portion of each of the plurality ofproximal-side struts overlap with a portion of at least one of theplurality of proximal-side struts adjacent thereto at a discretelocation and a portion of each of the plurality of distal-side strutsoverlap with a portion of at least one of the plurality of distal-sidestruts adjacent thereto at a discrete location.
 2. The device of claim1, wherein in the deployed configuration the plurality of proximal-sidestruts form a plurality of proximal-side petal-shaped loops and theplurality of distal-side struts form a plurality of distal-sidepetal-shaped loops.
 3. The device of claim 2, wherein an expanded radiusof the central portion is less than an expanded radius of the pluralityof proximal-side petal-shaped loops and is less than an expanded radiusof the plurality of distal-side struts while the occluder is in thedeployed configuration.
 4. The device of claim 2, wherein eachproximal-side petal-shaped loop of the plurality of proximal-sidepetal-shaped loops overlaps with one or more other proximal-sidepetal-shaped loops of the plurality of proximal-side petal-shaped loops.5. The device of claim 2, wherein a total number of proximal-sidepetal-shaped loops of the plurality of proximal-side petal-shaped loopsis unequal to a total number of distal-side petal-shaped loops of theplurality of distal-side petal-shaped loops.
 6. The device of claim 2,wherein the plurality of proximal-side petal-shaped loops are radiallyoffset from the plurality of distal-side petal-shaped loops.
 7. Thedevice of claim 1, wherein the occluder body is formed from a tube,wherein each of the plurality of proximal-side struts, the plurality ofdistal-side struts, and the plurality of central struts are defined byslits in the tube, and wherein each of the proximal end portion, theproximal convergence area, the distal convergence area, and the distalend portion comprise portions of the tube that do not include slits suchthat at least the distal convergence area and the proximal convergencearea are configured to maintain a non-expanded tubular profile upon areconfiguration of the occluder body from the delivery configuration tothe deployed configuration.
 8. The device of claim 1, wherein thecentral portion comprises a different number of struts than at least oneof the distal and proximal sides of the occluder body.
 9. A device foroccluding a defect in a body, the device comprising: an occluder bodythat defines a longitudinal axis, the occluder body being reconfigurablefrom an elongated delivery configuration to a shortened and radiallyexpanded deployed configuration, the occluder body comprising: aproximal end portion; a proximal convergence area that is positioneddistal of the proximal end portion; a plurality of proximal-side strutsthat extend between the proximal end portion and the proximalconvergence area to define a proximal side; a distal convergence areathat is positioned distal of the proximal convergence area; a pluralityof central struts that extend between the proximal convergence area andthe distal convergence area to define a central portion, and portions ofthe plurality of central struts are non-overlapping and form asubstantially circular perimeter while the occluder body is configuredin the deployed configuration; a distal end portion that is positioneddistal of the distal convergence area; and a plurality of distal-sidestruts that extend between the distal convergence area and the distalend portion to define a distal side, wherein each of the proximal endportion, the proximal convergence area, the distal convergence area, andthe distal end portion are disposed generally coaxially in relation tothe longitudinal axis while the occluder body is configured in thedelivery configuration, wherein while the occluder body is configured inthe delivery configuration each of: (i) the plurality of proximal-sidestruts, (ii) the plurality of central struts, and (iii) the plurality ofdistal-side struts are arranged radially outward from the longitudinalaxis while each of: (a) the proximal end portion, (b) the proximalconvergence area, (c) the distal convergence area, and (d) the distalend portion remain disposed generally coaxially in relation to thelongitudinal axis and in the deployed configuration, a portion of eachof the plurality of proximal-side struts overlap with a portion of atleast one of the plurality of proximal-side struts adjacent thereto at adiscrete location and a portion of each of the plurality of distal-sidestruts overlap with a portion of at least one of the plurality ofdistal-side struts adjacent thereto at a discrete location, wherein theoccluder body is formed from a tube, wherein slits in the tube defineeach of: (1) the plurality of proximal-side struts, (2) the plurality ofdistal-side struts, and (3) the plurality of central struts.
 10. Thedevice of claim 9, wherein in the deployed configuration the pluralityof proximal-side struts form a plurality of proximal-side petal-shapedloops and the plurality of distal-side struts form a plurality ofdistal-side petal-shaped loops.
 11. The device of claim 10, wherein anexpanded radius of the central portion is less than an expanded radiusof the plurality of proximal-side petal-shaped loops and is less than anexpanded radius of the plurality of distal-side struts while theoccluder is in the deployed configuration.
 12. The device of claim 10,wherein each proximal-side petal-shaped loop of the plurality ofproximal-side petal-shaped loops overlaps with one or more otherproximal-side petal-shaped loops of the plurality of proximal-sidepetal-shaped loops.
 13. The device of claim 10, wherein a total numberof proximal-side petal-shaped loops of the plurality of proximal-sidepetal-shaped loops is unequal to a total number of distal-sidepetal-shaped loops of the plurality of distal-side petal-shaped loops.14. The device of claim 10, wherein the plurality of proximal-sidepetal-shaped loops are radially offset from the plurality of distal-sidepetal-shaped loops.
 15. The device of claim 9, wherein the plurality ofcentral struts are parallel with the longitudinal axis while theoccluder body is configured in the delivery configuration.
 16. Thedevice of claim 9, wherein the central portion comprises a differentnumber of struts than at least one of the distal and proximal sides ofthe occluder body.
 17. The device of claim 9, wherein each of (i) theproximal end portion, (ii) the proximal convergence area, (iii) thedistal convergence area, and (iv) the distal end portion compriseportions of the tube that do not include slits.